BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 4538615 · Received February 23, 2015

    Report

    Report Number
    3009897021-2015-00009
    Event Type
    Injury
    Date Received
    February 23, 2015
    Report Date
    January 23, 2015
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INCLUDED IN THIS STUDY WAS TREATED WITH NEGATIVE PRESSURE WOUND THERAPY FROM 2008 TO 2013. IT IS UNKNOWN WHEN THE EVENTS OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED ESCHAROTOMIES OR TISSUE SWELLING ARE RELATED TO V.A.C. THERAPY. THE PATIENTS TREATED IN THIS STUDY EXPERIENCED DEEP DERMAL FOOT SCALDS. BURN WOUNDS CAN RESULT IN FORMATION OF ESCHAR, AND AN ESCHAROTOMY IS USED TO TREAT BURN INDUCED COMPARTMENT SYNDROME. THEREFORE, IT UNKNOWN IF THE SWELLING AND SUBSEQUENT ESCHAROTOMIES ARE RELATED TO V.A.C. THERAPY. KCI HAS MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (JAN 26, 2015; FEB. 03, 2015; FEB. 13, 2015; FEB. 19, 2015). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    KCI RECEIVED ARTICLE, KISCH, TOBIAS, ET AL. REDUCED AMPUTATION RATE BY CIRCULAR TNP APPLICATION ON SPLIT-SKIN GRAFTS AFTER DEEP DERMAL FOOT SCALDS IN INSULIN-DEPENDENT DIABETIC PATIENTS. JOURNAL OF BURN CARE AND REHABILITATION. 22 (2001) -26 (2005) 11/2014; DOI: (B)(4) THAT REPORTED AN ESCHAROTOMY WAS NEEDED TWICE IN THE TOPICAL NEGATIVE PRESSURE GROUP (TNP) DUE TO CRITICAL TISSUE SWELLING. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT'S TYPE AND SERIAL NUMBERS WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126884 V.A.C. THERAPY OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention